NCT02332330

Brief Summary

This study is designed to collect post market data on use of the VEST, particularly on saphenous vein grafts to the right territory of the heart.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2015

Geographic Reach
2 countries

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2015

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

January 4, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 6, 2015

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2016

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2016

Completed
Last Updated

April 28, 2016

Status Verified

October 1, 2015

Enrollment Period

1 year

First QC Date

January 4, 2015

Last Update Submit

April 27, 2016

Conditions

Coronary Artery Bypass Surgery

Outcome Measures

Primary Outcomes (2)

  • Vein graft patency by CT angiography

    3-6 monthws

  • MACCE

    Major adverse cardiac and cerebral events

    3-6 months

Study Arms (1)

VEST

EXPERIMENTAL
Device: VEST

Interventions

VESTDEVICE
VEST

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patient scheduled for on-pump CABG on clinical grounds
  • At least one vein graft bypass indicated for right coronary artery and LIMA indicated for the LAD on clinical grounds
  • Appropriately sized and accessible target coronary arteries, with a minimum diameter of 1.5 mm and adequate vascular bed, as assessed from the pre-operative cardiac angiography.

You may not qualify if:

  • Concomitant non-CABG cardiac procedure
  • Prior cardiac surgery
  • Emergency CABG surgery (cardiogenic shock, inotropic pressure support, IABP)
  • Contraindication for on-pump CABG with cardioplegic arrest (e.g. severely calcified aorta)
  • Calcification at the intended anastomotic sites, as assessed upon opening of the chest and before VEST implantation.
  • Prior debilitating stroke less than 1 year before surgery
  • Severe renal dysfunction (Cr\>2.0 mg/dL)
  • Concomitant life-threatening disease likely to limit life expectancy to less than 2 years.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Krankenhaus der Barmherzigen Bruder

Trier, Germany

Location

The John Radcliffe Hospital

Oxford, United Kingdom

Location

Study Officials

  • David P Taggart, Professor

    Oxford University Hospitals NHS Trust

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 4, 2015

First Posted

January 6, 2015

Study Start

January 1, 2015

Primary Completion

January 1, 2016

Study Completion

April 1, 2016

Last Updated

April 28, 2016

Record last verified: 2015-10

Locations

GB(1)DE(1)